EXTON, Pa.--(BUSINESS WIRE)--Nuron Biotech Inc., a specialty biologics and vaccines company, today announced the initiation of a randomized, double-blind, placebo-controlled, pivotal Phase 3 study to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS). NU100 is a proprietary recombinant human interferon beta-1b (IFN beta-1b) being developed as a new molecular entity. The product is an essentially aggregate-free liquid formulation produced utilizing an advanced processing technology.
“Nuron Biotech has assembled a proven management team, established a quality pipeline in multiple disease areas and worked very diligently to advance our lead compound into Phase 3,” said Shankar Musunuri, Ph.D., MBA, Chief Executive Officer and Founder of Nuron Biotech. “We are making excellent progress toward our goal of bringing innovative and improved biologics to markets in need.”
The Phase 3 study involves 500 patients from approximately 125 clinical sites across Europe and Asia. Patients will be randomized to receive NU100, a marketed IFN beta-1b or placebo and will be treated over a 12-month period. The study is designed to measure the safety and efficacy of NU100.
“This pivotal trial is unique in that we have designed it in collaboration with regulatory authorities as a one-year study to assess the safety and efficacy of this product,” said Tracy Goeken, M.D., Vice President, Clinical and Medical Affairs of Nuron Biotech. “We expect data from this study in late 2013.”
About NU100
NU100 is a proprietary recombinant human interferon beta-1b produced utilizing proprietary refolding process technology. It is being developed as a standalone molecule for the treatment of relapsing remitting multiple sclerosis (RRMS) and as a new molecular entity based on positive opinion from the European Medicines Agency and the Food and Drug Administration. Patients treated with currently marketed interferon beta-1b products have up to 40 percent neutralizing antibody prevalence after two years of treatment. NU100 is essentially aggregate-free compared to those products; therefore, it should result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.
About Nuron
Nuron Biotech’s vision is to bring innovative and improved biologics to market for the better health of patients. Nuron’s management team consists of proven veteran industry executives who have made significant contributions in developing, launching and managing the life cycle of various biologics.
Nuron is currently working on products in three disease areas: central nervous system (CNS), wound healing and vaccines. www.nuronbiotech.com